Profile: Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Our cardiovascular instruments includes peripheral vascular, aorta, anastomosis clamps, vascular clips and bulldog clamps, tissue and organ grasping forceps, rib and sternum retractors, valve retractors, microsurgical instruments including scissors, needle holders, forceps, ligation clips, pediatric, and sternum saw. Our columbus knee is a knee implant truly designed for use with computer assisted navigation. Our Safil® Quick is a braided absorbable suture, which provides high initial tensile strength & ultra smooth passage through tissue. Our MonoPlus® is a long-term absorbable monofilament suture made of polydioxanone. MonoPlus gives a great combination of outstanding characteristics, high tensile strength and smooth tissue passage.

The company was founded in 1977, has revenues of USD 1-5 Million, has ~120 employees.

FDA Registration Number: 2916714

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• Bone Hooks (FDA Code: KIK / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Bone Mill (FDA Code: LYS / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Bone Rongeurs

• Bone Screw Starter (FDA Code: HWD / 888.4540)

• Bone Wax (FDA Code: MTJ)

• Breathing Mouthpiece (FDA Code: BYP / 868.5620) A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

• Breathing System (Calibrated) Collection Bottle (FDA Code: CBD / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Broach (FDA Code: HTQ / 888.4540)

• Buck Ear Curettes

• Bulb Suction Tip

• Burr Hole Cover (FDA Code: GXR / 882.5250) A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

• Calipers (FDA Code: KTZ / 888.4150) A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.

• Cannula Clamp (FDA Code: FKC / 876.5540) A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

• Cardiac Suction Tubes

• Cardiovascular Biopsy Needle (FDA Code: DWO / 878.4800)

• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• Cardiovascular Surgical Saw Blade (FDA Code: DWH / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• Catheter Accessories (FDA Code: KGZ / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Catheter Adaptor (FDA Code: GCE / 878.4200)

• Catheter Dilator (FDA Code: GCC / 878.4200)

• Catheter Needle (FDA Code: GCB / 878.4200)

• Catheter Punch Instrument (FDA Code: FEX / 876.5090) A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

• Central Nervous System and Components (FDA Code: JXG / 882.5550) A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.

• Cervical Biopsy Punch

• Child Ear Curette

• Circular Dermal Biopsy Punch

• Clip Rack (FDA Code: HBR / 882.4215) A clip rack is a device used to hold or store surgical clips during surgery.

• Clip Removal Instrument (FDA Code: HBQ / 882.4200) A clip removal instrument is a device used to remove surgical clips from the patient.

• Clip Surgical Applier (FDA Code: GDO / 878.4800)

• Collagen Bilayered Dural Substitute

• Common Duct Scoop

• Computed Tomography X-Ray System (FDA Code: JAK / 892.1750) A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Computer Softwares

• Continuous Intracranial Pressure Monitor (FDA Code: GWM / 882.1620) An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.

• Corkscrew (FDA Code: HWI / 888.4540)

• Coronary Needle Holders

• Cosmetic Surgery, Needle Holder (Serrated)

• Countersink (FDA Code: HWW / 888.4540)

• Cranial Basics Dural Substitute

• Cranial Drill

• Crile Wood Needle Holder

• Crimp Pliers (FDA Code: FJY / 876.5540)

• Crimp Ring (FDA Code: FJX / 876.5540)

• Curettes

• Curved Carbide Jaw Needle Holder

• Dental Mouth Gag

• Dermabrasion Brush (FDA Code: GFE / 878.4820)

• Dermal Biopsy Punch (FDA Code: FCI / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Dermatomes (FDA Code: GFD / 878.4820)

• Detachable Kerrison Punches